Clinical Trial

A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)

Recruiting Phase 3
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Summary
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) and interstitial lung disease associated with other connective tissue diseases (CTD-ILD), respectively. The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-11-29; most recent amendment 2025-12-02.
Status change: Not Yet Recruiting → Recruiting 2025-01-06
Trial Details
NCT Number NCT06716606
Lead Sponsor GlaxoSmithKline
Collaborators: ICON plc
Conditions Connective Tissue Diseases
Enrollment 514 participants
Start Date 2024-12-12
Primary Completion 2029-12-27 (estimated)
Study Completion 2029-12-27 (estimated)
Updated on ClinicalTrials.gov 2025-12-09